The Eijkman-Oxford Clinical Research Unit (EOCRU) in Jakarta opened in 2008 with the signing of a memorandum of understanding between the Eijkman Institute for Molecular Biology and the University of Oxford, to conduct collaborative research on infectious diseases impacting the health of Indonesians and residents of other Southeast Asian nations. University of Oxford also has a partnership (MoU) with Universitas Indonesia, and they jointly established the Universities of Indonesia and Oxford Clinical Research Laboratory (IOCRL) which is a facility dedicated to supporting collaborative clinical research between the universities. EOCRU is also part of the Oxford Tropical Network with research units in Africa, Asia and UK, and operates under the auspices of the Oxford University Clinical Research Unit in Vietnam.
Clinical trials of chemotherapeutics, diagnostics and vaccines for tropical infections of public health importance in Indonesia, principally malaria, tuberculosis, antimicrobial resistance, and other emerging and neglected tropical diseases, form the core of EOCRU’s activities, with associated epidemiological, laboratory, and clinical research. EOCRU aims to have a positive and significant impact on the prevention, diagnosis and treatment of infectious diseases to improve patient care in Indonesia and the region. This is being achieved via an expanding long-term research programme with our local hosts and partners, contributions to research training, and public engagement with science. Current EOCRU core staff includes 3 Oxford-employed expatriate scientists, 10 Indonesian scientists, 6 administrative and finance support staff, and approximately 30 clinical trials support staff.
In conducting their work in Indonesia, EOCRU is assisted by Alliance for Emerging and Re-emerging Disease Threats in Asia Foundation (ALERTAsia), a local foundation assisting in research grant management and capacity building for local researchers.
Through ALERTAsia we are seeking a qualified and experienced Clinical Research Operations Manager to support our growing portfolio of clinical research, The post-holder’s primary responsibility is overseeing and developing clinical trials operations of high quality and efficiency within EOCRU, which are in line with the Good Clinical Practice (GCP) and international regulatory standards. This vacancy offers an exciting opportunity for an active professional to take a leading role in contributing to the further development and professionalization of the clinical research capacities with EOCRU and its partners. The post-holder will be responsible for team management and assure the successful execution of all EOCRU clinical research/studies
Job Description
The Clinical Research Operations Manager will have the following responsibilities:
- Lead and develop the clinical trials operations team consisting of study coordinators, study clinicians, pharmacists, data managers, and laboratory to ensure execution of high quality clinical research studies.
- Oversee the clinical research governance team consisting of trial administrators and monitors to ensure that all research complies with national and international regulations. This includes maintaining an up-to-date understanding of the applicable trial regulations, train investigators on regulatory changes and ensure that these standards are implemented in all research activities.
- Contribute to the decision-making process for how clinical trials are optimally managed at the Unit together with the Head of Unit and the Scientific Committee.
- Advise within the Unit and all collaborators on all matters relating to operational support of planned and ongoing clinical trials including management, monitoring, and evaluation.
- Implement the Unit’s policies on the conduct of clinical trials.
- Ensuring quality and consistency across all clinical research conducted within the clinical operations team
- Undertaking any other duties consistent with the grade as requested by the Head of Unit.
- Frequently liaise/meet with the Principal Investigators, investigators and EOCRU staff.
- Work with the trial staff at all sites to ensure that studies are executed in compliance with the protocol and applicable local and international regulatory standards.
- Support EOCRU and site staff to:
- Implement required training for research staff, particularly in the areas of human subjects’ protection, protocol related procedures and good clinical practice.
- Develop data and operational tools to deliver research studies including protocol specific Case Report Forms, Standard Operating Procedures, Data Management Plan, DSMB Charter, Informed Consent Forms, Monitoring Plan, Regulatory documentation and training.
- Design standard procedures for study related activities including laboratory, clinical and data management processes.
- Oversee the pharmacy, data management and logistics for trials.
- Ensuring reports are provided to the necessary stakeholders in a timely manner
- Achieve research targets and address operational issues.
Benefits
The selected candidate will receive a three months contract and, if can show professionalism and work dedication, a possibility to receive long term contract and remuneration package that includes annual leave, sick leave, THR, optional private medical cover, BPJS Kesehatan, and not to mention fully paid income tax and BPJS Ketenagakerjaan (JAMSOSTEK). The salary shall be competitive and dependent upon qualifications and salary history.
Job Requirements
Qualifications
- Any higher level education (Bachelor of Science, Medical Doctor, Masters or PhD in Science, Public Health) or a related and equivalent degree.
- Project management experience with at least three years experiences of managing a large team.
- Significant experience in and in depth understanding of all aspects of clinical trials and in the conduct of clinical trials compliant with ICH-GCP guidelines.
- Strong diplomatic skills.
- Actual or near fluent in spoken English and Bahasa Indonesia
- Proven oral and written presentation skills.
- Excellent communication and interpersonal skills.
- High level of organisational and record keeping skills.
Desirable Criteria:
- Experience conducting or managing clinical trials in Indonesia or South East Asia.
- Work experience in a health research institution.
How to Apply
Application requirement (Cover Letter, CV, three name and address of professional referees, and your salary history) should be sent via e-mail to: hro@alertasia.org.
Please quote the reference “EOCRU-CROM” on your email subject. Shortlisting candidates will start immediately. Please submit your application by 9 November 2019; 0500 p.m
